Roughly 80% of human brain volume is made up by the neocortex, a set of highly interconnected layers of neurons that controls our higher brain functions, such as perception, cognition, motor control, and language. This massively parallel architecture is the initial inspiration for Deep Learning – a neural network paradigm that excels at pattern recognition and classification.
The US Food and Drug Administration (FDA) published a draft guidance document in December 2021 outlining transition plans for medical devices currently marketed under Emergency Use Authorizations (EUAs) during the COVID-19 public health emergency (PHE). The FDA has issued EUAs for a vast array of medical devices during the pandemic including ventilators, infusion pumps, personal protective equipment, in vitro diagnostics and more.
Medical devices, especially complex ones with electronics, almost always undergo shipping testing before they are considered safe enough for market. We use 3rd party testing services to run typical load profiles on devices in their packaging. These usually include impact, drop and vibration testing, amongst others. Vibration testing is a particularly interesting subject, which we’ll discuss here. You should also take a look into our blog on Medical Device Drop and Push Tests per IEC 60601-1.
Managing medtech stakeholder expectations is an important element of medical device development success. Investors, Internal stakeholders, KOLs, Clinicians, Scientists and Engineers will all play a part in shaping and delivering a successful medical device. We asked key members of our team to share their best tips and lessons learned. Here are 8 tips to manage medtech stakeholder expectations from our engineers, regulatory and quality assurance, and system engineers, and project managers.
The FDA’s Center for Devices and Radiological Health’s (CDRH) Office of Science and Engineering Labs (OSEL) is a part of FDA’s initiative to speed up medical device development and patient access to safe and effective medical devices by producing tools using innovative science in the assessment of new medical devices.
A Catalog of Regulatory Science Tools (RSTs) was developed by OSEL to expand the scope of science-based approaches used in the development of emerging medical technologies. These RSTs can be used by the industry to drive innovation and assess emerging medical technologies. The Catalog includes more than 100 RSTs, including laboratory methods, tissue-mimicking phantoms, and computational modelling and simulations.
I love farming, particularly growing fruit-bearing trees. It starts by planting seeds in a pot with soil. There are two types of seeds – monocots and dicots. I am really fascinated with the dicot type, also known as dicotyledons, for having two embryonic leaves. It is amazing to see the seed starting to grow with two embryonic leaves and a new leaf emerging in between.
Every year StarFish designs a unique holiday gift as a fun way to celebrate the season. This year we developed a zoetrope that creates the illusion of an unfurling, dahlia-like flower sculpture in three dimensions while glowing softly from within. Although this design challenge was not a medical device, it provided a great chance to put our engineering and design expertise to use. You should also take a look into the blog by Kevin Meric on Algorithm Aided Design (AAD).
Where do medical device development professionals go for answers?
Everyone has a “go-to” resource when they get stuck with a question or challenge they have not encountered before. StarFish employees specialize in designing and developing novel medical devices. We asked them for their favorite medical device development resources and tips:
International Women’s Day is an inspirational moment to celebrate women across all cultures, industries, and professions. We contemplated what we, as women in STEM, wanted to share on behalf of StarFish Medical on social media for this year’s theme of ‘Break the Bias’. In doing so, we also reflected on how we could contribute to better balancing the representation of women within the STEM industry.
One way to judge the fit of a potential new employer is to hear what attracted current employees and how well the company is meeting their expectations. This blog shares employee impressions prior to joining and their experiences being part of the team.
“A job interview is not a test of your knowledge, but your ability to use it at the right time.”
Is the purpose of a job interview a process to test the candidate’s ability or is there more to it? Should interviewers also try to understand whether a candidate is a cultural fit with the organisation and the job? This blog shares insights from Vicki Barton, Accounting Manager and recent hires – Ali Bahrani, Jr. S/W Engineer, Maria Gonzalez, Jr. QA Specialist, and Ali Hamood, Firmware/Software Engineer at ViVitro Labs.
An award-winning culture is not the work of a single individual or even a handful of individuals. Yes, it’s true that the tone comes from the top, but there are many “tops” in any organization and thus many points at which the culture can falter. There are overall cultures and then there are subcultures. Every leader in the organization sets the tone for the subculture in their team. While we speak of culture as a single, monolithic thing, it’s not. And that’s what makes it so challenging to get right. Everyone in an organization impacts the culture.